Safety and Efficacy of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines

NCT05292638 | Completed Phase 1

• 1 other identifier: CKDB-BAGL-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A single-center, randomized, double-blind, single-injection, active-controlled, parallel-design study to evaluate the safety and efficacy of CKDB-501A in Glabellar lines.

Conditions

Glabellar Lines

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events

  severity and frequency of reported adverse events

  up to week 12

Secondary Outcomes (5)

• Proportion of subjects with improvement in investigator-assessed glabellar line severity at maximum frown at each follow-up visit

  Week 4, 8, 12

• Proportion of subjects with improvement in investigator-assessed glabellar line severity at rest at each follow-up visit

  Week 4, 8, 12

• Changes in the investigator-assessed glabellar line severity score from baseline at each follow-up visit

  Week 4, 8, 12

• Proportion of subjects with improvement in subject's assessment of glabellar line severity at each follow-up visit

  Week 4, 8, 12

• Subject-assessed satisfaction scale at each follow-up visit

  Week 4, 8, 12

Study Arms (2)

CKDB-501A

EXPERIMENTAL

Drug: CKDB-501A

Botox®

ACTIVE COMPARATOR

Drug: Botox®

Interventions

CKDB-501A DRUG

Intramuscular injection CKDB-501A

CKDB-501A

Botox® DRUG

Intramuscular injection Botox®

Botox®

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with at least moderate glabellar frown lines at maximum frown using the severity score of at least 2(moderate) on the Facial Wrinkle Scale (4-point FWS)

You may not qualify if:

• Any medical condition (e.g., myasthenia gravis, Lambert-Easton syndrome, amyotrophic lateral sclerosis, etc.) that can affect the neuromuscular function
• History of facial nerve paralysis or ptosis
• Significant facial asymmetry
• Subjects with skin abnormalities such as infection, dermatologic disorders, scars, etc. at potential injection sites
• Previous treatment with any serotype of botulinum toxin products within 24 weeks (6 months) prior to Screening or planning to receive treatment with botulinum toxin during the study period
• Previous treatment with retinoids (isotretinoin, alitretinoin, etc.)

Sponsors & Collaborators

• CKD Bio Corporation: lead

Study Sites (1)

Chung-Ang University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• beomjoon Kim

  Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Active-controlled

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 23, 2022
• Study Start: February 15, 2022
• Primary Completion: June 10, 2022
• Study Completion: June 10, 2022
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)